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Completed

NCT Number: NCT06273735

Prospective Trial: Acute Myocardial Injury After Radical Prostatectomy

This prospective observational study investigates the incidence of acute myocardial injury after radical prostatectomy for prostate cancer. Consecutive patients undergoing elective open or robot-assisted radical prostatectomy at the Martini-Klinik are included. High-sensitivity cardiac troponin I (hs-cTnI) is measured preoperatively and on postoperative days 1 and 2 to identify acute myocardial injury, defined according to the 4th Universal Definition of Myocardial Infarction. Secondary outcomes include the incidence of myocardial infarction, major adverse cardiac and cerebrovascular events, and mortality during the hospital stay and at 24 months. Baseline patient characteristics (age, BMI, cardiovascular risk factors including the Revised Cardiac Risk Index, comorbidities, and prior cardiac therapy) as well as surgical and tumor-specific parameters are recorded. Associations between acute myocardial injury and clinical variables are analyzed.

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Key information

About this study

Primary endpoint:

Acute myocardial injury, defined as a postoperative troponin concentration above the 99th percentile sex-specific upper reference limit with a) an increase of ≥ 50% from baseline if the baseline troponin I or T concentration was below the 99th percentile sex-specific upper reference limit or with b) an increase of ≥ 20% from baseline if the baseline troponin I or T concentration was above the 99th percentile sex-specific upper reference limit. percentile or with b) an increase of ≥ 20 % compared to the initial value if the initial troponin I or T concentration was above the sex-specific upper reference limit of the 99th percentile.

Secondary endpoints:

  • recording the frequency of acute myocardial damage without or with clinical findings typical of ischaemia.
  • frequency of cardiovascular events during hospitalisation. Cardiovascular events are defined as follows: non-fatal cardiac arrest, heart failure, interventional coronary angiography, coronary artery bypass surgery, new-onset atrial fibrillation, stroke, pulmonary artery embolism, deep vein thrombosis of leg or arm.
  • correlation between the level of postoperative troponin increase and the occurrence of cardiovascular events during hospitalisation.
  • predictive value of the Revised Cardiac Risk Index for the occurrence of acute myocardial damage.
  • differences in the incidence of acute myocardial damage in open radical prostatectomies versus minimally invasive radical prostatectomies.

Furthermore, the included patients are followed up for 24 months and questioned about cardiovascular events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consent form signed
  • Patients with a biopsy-proven prostate carcinoma
  • planned ORP or RARP

Exclusion criteria

  • No exclusion of patients who fulfil the above inclusion criteria

Treatment and study plan

Pre- and postoperative determination of troponin as part of the study and 24-month FU survey

Diagnostic Test

An intervention is carried out as part of the normal clinical procedure regardless of the study measurement parameters.

Primary outcomes

  1. rate of acute myocardial injury in standardised open and robot-assisted radical prostatectomy

    Time frame: the day before surgery until 24months follow-up

    Survey of the rate of asymptomatic and symptomatic myocardial damage. A troponin determination is carried out before the prostatectomy as well as a troponin determination on the first and second postoperative day. An ACS is recorded clinically. Myocardial events and treatment of myocardial infarction are also recorded during the follow-up.

Sponsors and collaborators

Lead sponsor

Martini-Klinik am UKE GmbH

Other

Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

Registry information

Official study title

Evaluation of Intra- and Postoperative Cardiac Events in Patients With Localised Prostate Carcinoma and Radical Prostatectomy

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 22, 2024
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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